Breg VPULSE Cold Therapy System

Breg VPULSE Breg VPULSE Cold Therapy System improves patient outcomes, reduces the total cost of the orthopedic episode and increases patient satisfaction to deliver more time well spent. VPULSE helps patients achieve complete, comfortable recoveries through delivery of therapies. It is designed to provide a continuity of care from the hospital, surgery center, and clinic to self-treatment at home, the VPULSE helps patients comply with post-operative instructions.

Lowers Risk of Venous Thromboembolism (VTE):- VPULSE lowers incidence of VTE after major orthopedic surgery compared to pharmacological prophylaxis- VTE is the leading factor for hospital readmission following major orthopedic surgery and the most common preventable cause of hospital death

Provides Possible Alternative to Anticoagulants:- VPULSE offers physicians another option to help tailor preventative care to patient risk and provides an alternative for patients contraindicated for anticoagulants

Provides Convenient Home Therapy:- As hospital stays continue to shorten, VPULSE provides a solution for patients to take home and keep- Allows facilities to offer mechanical DVT prophylaxis for the 2-3 weeks patients need it most, without the hassle of renting or servicing equipment

Improves Patient Experience: Combining three therapies into one convenient device optimizes patient comfort during recovery.- With motorized cold therapy and accompanying water bottles, patients avoid the hassle of frequently switching out ice cubes or gel packs

Lowers Total Cost:- Bundled payment of care initiatives are driving single payment for an orthopedic episode within 30 days of surgery, including costly DVT readmissions- By reducing DVT-related expenses and potentially reducing costs for anticoagulant regimes or compression device rental programs, VPULSE helps reduce the total cost of the episode

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Applying Therapy Wraps and Pads:- Apply therapy pads only to body part indicated for the associated pad, failure to follow the product instructions may lead to improper product performance and the potential for serious injury- Apply the Sequential Compression Therapy pads to the calves of the patient

Center the pad behind the calf of the patient

Wrap one side of the pad, around the front of the leg of the patient

Secure by wrapping the 3 "fingers" in the order shown around to the front

Contraindications:- Cold Therapy: Medical professionals and patients should be aware of situations where cold therapy may not be appropriate, detrimental to a specific condition or otherwise contraindicated for use, including patients with:- Diabetes- Cold uticaria- Cryoglobulinemia- Raynauds syndrome- Proximal cold hemoglobinuria- Vasospastic disease- Cold hypersensitivity- Compromised local circulation- History of cold injury, frostbite, or adverse reactions to local cold application- Patients who are incoherent due to general anesthesia, sedation, or coma â€¢ Local tissue infection- Hand/wrist or feet/ankle surgery with polyneuropathy

Cleaning your VPULSE:- Remove electrical cord.- Fill the empty water container to the MAX fill line with fresh, room temperature water.- Do not use any cleaning solutions in the water reservoir as these solutions could damage the water pump and therapy pads.- Replace the handle and connect power. Connect all pads and enable all functions.- Operate the system for 10 minutes.- Empty the water reservoir.- Repeat these actions periodically.- Please use only the following cleaning agents when cleaning the outside of VPULSE system:

- Patients should not use cleaning or decontamination methods different from those recommended by the manufacturer without first checking with the manufacturer that the proposed methods will not damage the equipment.

Care and Maintenance:- Do not store the pad in its shipping bag.- The shipping bag may trap the moisture remaining in the pad.- Store the VPULSE unit in a safe, cool and dry place when not in use.- Ensure the water container is empty of water and dry to avoid bacterial growth and contamination.- Wipe down the device with a soft, damp cloth.- Do not use abrasive cleaner.- Never immerse the unit into any liquid.- Keep away from all solvents and harsh detergents.- Please refer to cleaning instructions prior to cleaning VPULSE.- Do not attempt to repair the VPULSE.- There are no patient-serviceable parts.- Repair of the system by an unauthorizedÂ personÂ may void the product warranty.- To store, disconnect the electrical cord, the tubing set and the pad.

Storage:- Remove water from the Thermal-Compression pad by rolling the pad up while still connected and squeezing the water back into the Container.- Remove the Ice Bottles from the unit.- Separate the bottles and pour the water out, air dry.- Dump the water out of the side Control Unit so that the control buttons and other electrical components stay dry.- When empty, let the unit air dry completely.- For long term storage, please use the shipping materials and container supplied with the VPULSE.

Warnings: Cold Therapy- If the patient has any of the following clinical risk factors, use of cold therapy may result in serious cold-induced injury, including full thickness skin necrosis:

Cold application area desensitization due to local anesthesia or regional nerve block

Taking medications that have a negative effect on peripheral vascular circulation, including beta adrenergic blockers and local epinephrine use (such as in local anesthetics)

- If the risk of cold-induced injury outweighs the benefits of cold therapy, do not prescribe the VPULSE cold therapy. If you prescribe this product to patients with risk factors, consider taking special measures to control the risk, such as:

- The VPULSE can be cold enough to cause serious injury including full skin necrosis.- Excessive moisture at the application site due to excessive bleeding, sweating, or condensation may increase the risk of serious cold-induced injury, including full thickness necrosis.- Inspect the skin under the cold therapy pad (by lifting the edge) as prescribed, typically every 1 to 2 hours.- Do not use VPULSE cold therapy if dressing, wrapping, bracing or casting over the cold therapy pad prevents skin checks. Stop using and contact your practitioner immediately if you experience any adverse reactions, such as:

Increased pain

Burning

Increased swelling

Itching

Blisters

Increased redness

Discoloration

Welts

Other changes in skin appearance

Any other reaction identified by your practitioner.

- Be aware of any nerve irritation and/or muscular reaction that are associated with skin sensitivity and irritation.- If observed, discontinue therapy until the cause is determined.- Do not operate without water in the system.- Doing so may damage your system and void the product warranty.

Note:Prescription is mandatory, it can be faxed to 1.203.616.2851 or emailed to[email protected]

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